MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202895

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy, the 'twinfix ultra, ti' anchor was placed on the pre-prepared bone and while screwing in (anchor sunk approx.Halfway) the tip of the setting instrument came loose, thus the anchor could not be screwed in any further.The inserter tip separate from the device construction and the loosened piece was retrieved from the anatomy.Patient bone quality was good.It is unknown if a void was left in the patient.The procedure was completed with a s+n back up device.There was a non-significant delay and no further complications were reported.

Event Description

It was reported that during an cuff reconstruction supraspinatus tendon, the 'twinrix ultra, ti' anchor was placed on the pre-prepared bone and while screwing in (anchor sunk approx.Halfway) the tip of the setting instrument came loose, thus the anchor could not be screwed in any further.The inserter tip separate from the device construction and the loosened piece was retrieved from the anatomy.Patient bone quality was good.No void was left in the patient.The procedure was completed with a s+n back up device.There was a non-significant delay and no further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A visual inspection of the returned product found the insertion device returned outside the original packaging.The distal tip of the inserter is broken from the shaft.There were no sutures or anchor returned.There is debris on the device.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Our clinical investigation concluded: based on the information provided, the surgeon did not leave a voided hole in the patient and the procedure was completed with a s+n back up device with a non-significant delay.Since there was no harm alleged to this patient or other complications reported, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided this cause would be re-assessed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during a cuff reconstruction supraspinatus tendon, the 'twinfix ultra, ti' anchor was placed on the pre-prepared bone and while screwing in (anchor sunk approximately halfway), the tip of the setting instrument came loose, thus the anchor could not be screwed in any further.The inserter tip separated from the device construction and the loosened piece was retrieved from the anatomy.No void was left in the patient.The procedure was completed after a non-significant surgical delay with a s+n back up device.No further complications were reported.

• Brand Name: TWINFIX ULTRA 5.5MM W/2 UB (WHT & BLUE)
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13841286
• MDR Text Key: 287554814
• Report Number: 1219602-2022-00397
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010652263
• UDI-Public: 03596010652263
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202895
• Device Catalogue Number: 72202895
• Device Lot Number: 2082530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male